Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy (CONDOR)

A 96-week, Two-arm, Randomized, Single-masked, Multi-center, Phase III Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

The purpose of this study is to evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR). This evaluation will provide information that brolucizumab is non-inferior to PRP with respect to the change in best corrected visual acuity at Week 54.

Study Overview

• Status: Active, not recruiting
• Conditions: Proliferative Diabetic Retinopathy
• Intervention / Treatment: Biological: Brolucizumab 6 mg; Procedure: Panretinal photocoagulation laser

• Study Type: Interventional
• Enrollment (Actual): 689
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1061AAE
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, 1116
      • Novartis Investigative Site
    • Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1015ABO
      • Novartis Investigative Site
  • De Santa Fe
    • Rosario, De Santa Fe, Argentina, B7602
      • Novartis Investigative Site
• Australia
  • New South Wales
    • Albury, New South Wales, Australia, 2640
      • Novartis Investigative Site
    • Liverpool, New South Wales, Australia, 2170
      • Novartis Investigative Site
    • Parramatta, New South Wales, Australia, 2150
      • Novartis Investigative Site
    • Strathfield, New South Wales, Australia, 2135
      • Novartis Investigative Site
• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90035-903
      • Novartis Investigative Site
  • SC
    • Blumenau, SC, Brazil, 89052-504
      • Novartis Investigative Site
  • SP
    • Sao Paulo, SP, Brazil, 01427-002
      • Novartis Investigative Site
    • Sorocaba, SP, Brazil, 18031-060
      • Novartis Investigative Site
• Canada
  • Quebec, Canada, G1S 4L8
    • Novartis Investigative Site
  • Ontario
    • Ottawa, Ontario, Canada, K2B 7E9
      • Novartis Investigative Site
    • Toronto, Ontario, Canada, M5T 2S8
      • Novartis Investigative Site
  • Quebec
    • Boisbriand, Quebec, Canada, J7H 1S6
      • Novartis Investigative Site
• Chile
  • RM
    • Santiago, RM, Chile, 7560994
      • Novartis Investigative Site
• China
  • Beijing, China, 100730
    • Novartis Investigative Site
  • Beijing, China, 100050
    • Novartis Investigative Site
  • Beijing, China, 100191
    • Novartis Investigative Site
  • Shanghai, China, 200080
    • Novartis Investigative Site
  • Beijing
    • Beijing, Beijing, China, 100044
      • Novartis Investigative Site
  • Guangdong
    • Shantou, Guangdong, China, 515041
      • Novartis Investigative Site
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Novartis Investigative Site
    • Wuhan, Hubei, China, 430070
      • Novartis Investigative Site
  • Jiangsu
    • Nanjing City, Jiangsu, China, 210000
      • Novartis Investigative Site
    • Nantong, Jiangsu, China, 226000
      • Novartis Investigative Site
  • Jilin
    • Changchun City, Jilin, China, 130041
      • Novartis Investigative Site
  • Liaoning
    • Shenyang City, Liaoning, China, 110000
      • Novartis Investigative Site
  • Shaanxi
    • Xian, Shaanxi, China, 710004
      • Novartis Investigative Site
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Novartis Investigative Site
  • Tianjin
    • Tianjin, Tianjin, China, 300020
      • Novartis Investigative Site
    • Tianjin, Tianjin, China, 300070
      • Novartis Investigative Site
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325027
      • Novartis Investigative Site
• India
  • Chandigarh, India, 160012
    • Novartis Investigative Site
  • New Delhi, India, 110 029
    • Novartis Investigative Site
  • Gujarat
    • Ahmedabad, Gujarat, India, 380016
      • Novartis Investigative Site
  • Tamil Nadu
    • Coimbatore, Tamil Nadu, India, 641014
      • Novartis Investigative Site
  • Tamilnadu
    • Tirunelveli, Tamilnadu, India, 627003
      • Novartis Investigative Site
• Japan
  • Akita, Japan, 010-8543
    • Novartis Investigative Site
  • Osaka, Japan, 545-8586
    • Novartis Investigative Site
  • Aichi
    • Nagakute-city, Aichi, Japan, 480-1195
      • Novartis Investigative Site
    • Nagoya, Aichi, Japan, 466 8560
      • Novartis Investigative Site
  • Chiba
    • Sakura, Chiba, Japan, 285-8741
      • Novartis Investigative Site
  • Fukui
    • Yoshida-gun, Fukui, Japan, 910-1193
      • Novartis Investigative Site
  • Fukuoka
    • Kurume city, Fukuoka, Japan, 830-0011
      • Novartis Investigative Site
  • Fukushima
    • Koriyama, Fukushima, Japan, 963-8052
      • Novartis Investigative Site
  • Hokkaido
    • Asahikawa-city, Hokkaido, Japan, 078-8510
      • Novartis Investigative Site
  • Hyogo
    • Kobe-shi, Hyogo, Japan, 650-0017
      • Novartis Investigative Site
  • Kagawa
    • Kita-gun, Kagawa, Japan, 761-0793
      • Novartis Investigative Site
  • Mie
    • Tsu-city, Mie, Japan, 514-8507
      • Novartis Investigative Site
  • Nagano
    • Matsumoto, Nagano, Japan, 390-8621
      • Novartis Investigative Site
  • Tochigi
    • Shimotsuke, Tochigi, Japan, 329-0498
      • Novartis Investigative Site
  • Tokyo
    • Chiyoda-ku, Tokyo, Japan, 101-8309
      • Novartis Investigative Site
    • Hachioji-city, Tokyo, Japan, 193-0944
      • Novartis Investigative Site
    • Meguro-ku, Tokyo, Japan, 152-8902
      • Novartis Investigative Site
• Korea, Republic of
  • Daegu, Korea, Republic of, 705703
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 06351
    • Novartis Investigative Site
  • Gyeonggi Do
    • Bundang Gu, Gyeonggi Do, Korea, Republic of, 13620
      • Novartis Investigative Site
  • Seocho Gu
    • Seoul, Seocho Gu, Korea, Republic of, 06591
      • Novartis Investigative Site
• Mexico
  • Ciudad de Mexico, Mexico, 06760
    • Novartis Investigative Site
  • Tijuana, Mexico, 22010
    • Novartis Investigative Site
  • Distrito Federal
    • Ciudad De Mexico, Distrito Federal, Mexico, 06800
      • Novartis Investigative Site
• Philippines
  • Makati, Philippines, 1229
    • Novartis Investigative Site
  • Pasig City, Philippines, 1605
    • Novartis Investigative Site
  • NCR
    • Makati, NCR, Philippines, 1229
      • Novartis Investigative Site
• Puerto Rico
  • Arecibo, Puerto Rico, 00612
    • Emanuelli Research and Development Center LLC
• Russian Federation
  • Cheboksary, Russian Federation, 428028
    • Novartis Investigative Site
  • Ekaterinburg, Russian Federation, 620109
    • Novartis Investigative Site
  • Moscow, Russian Federation, 127486
    • Novartis Investigative Site
  • Moscow, Russian Federation, 127473
    • Novartis Investigative Site
  • Moscow, Russian Federation, 119021
    • Novartis Investigative Site
  • Omsk, Russian Federation, 644024
    • Novartis Investigative Site
  • Sterlitamak, Russian Federation, 453128
    • Novartis Investigative Site
  • Ulyanovsk, Russian Federation, 432063
    • Novartis Investigative Site
• Taiwan
  • Hualien, Taiwan, 970
    • Novartis Investigative Site
  • Kaohsiung, Taiwan, 80756
    • Novartis Investigative Site
• Turkey
  • Ankara, Turkey, 06100
    • Novartis Investigative Site
  • Istanbul, Turkey, 34420
    • Novartis Investigative Site
  • Izmir, Turkey, 35340
    • Novartis Investigative Site
• United States
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Retina Associates SW
  • California
    • Beverly Hills, California, United States, 90211
      • Retina Vitreous Assoc Medical Group .
    • Fullerton, California, United States, 92835
      • Retina Consultants of Orange County
    • Huntington Beach, California, United States, 92647
      • Salehi Retina Institute
    • Redlands, California, United States, 92374
      • Retina Consultants of Southern California .
    • Torrance, California, United States, 90509-2910
      • Lundquist Inst BioMed at Harbor .
    • Torrance, California, United States, 90505
      • Premiere Practice Management LLC
    • Ventura, California, United States, 93003
      • Novartis Investigative Site
  • Florida
    • Coral Springs, Florida, United States, 33067
      • Advanced Research LLC
    • Deerfield Beach, Florida, United States, 33064
      • Rand Eye Institute
    • Fort Lauderdale, Florida, United States, 33309
      • Novartis Investigative Site
    • Fort Myers, Florida, United States, 33912-7125
      • National Ophthalmic Research Institute Ophthalmology
    • Jacksonville, Florida, United States, 32216
      • Florida Retina Institute
    • Lakeland, Florida, United States, 33801
      • Novartis Investigative Site
    • Miami, Florida, United States, 33143
      • MedEye Associates Ophthalmology
    • Orlando, Florida, United States, 32804
      • Florida Retina Institute Ophthalmology
    • Panama City, Florida, United States, 32405
      • Eye Center of North Florida
    • Plantation, Florida, United States, 33324
      • Fort Lauderdale Eye Institute .
  • Illinois
    • Elmhurst, Illinois, United States, 60126
      • Retina Associates
  • Indiana
    • Indianapolis, Indiana, United States, 46280
      • Midwest Eye Institute .
    • New Albany, Indiana, United States, 47150
      • John-Kenyon American Eye Institute PC
  • Kansas
    • Lenexa, Kansas, United States, 66215
      • Retina Associates PA
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Cumberland Valley Retina Consultants
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Med Ctr .
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Retina Associates Of Cleveland .
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Dean McGee Eye Institute
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Cascade Medical Research Institute
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16507
      • Erie Retinal Surgery
  • South Carolina
    • Ladson, South Carolina, United States, 29456
      • Charleston Neuroscience Institute
  • Tennessee
    • Knoxville, Tennessee, United States, 37923
      • Southeastern Retina Associates P C .
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Retina Associates
    • Austin, Texas, United States, 78731
      • Texan Eye P A
    • Bellaire, Texas, United States, 77401
      • Retina And Vitreous Of Texas Ophthalmology 3
    • Bellaire, Texas, United States, 77401
      • Retina Consultants TX Rsrch Ctr
    • Fort Worth, Texas, United States, 76104
      • Texas Retina Associates
    • Harlingen, Texas, United States, 78550
      • Valley Retina Institute PA .
    • Houston, Texas, United States, 77030
      • Retina Consultants of Houston PA .
    • San Antonio, Texas, United States, 78240
      • Retina Associates Of South Texas PA CRFB002H2301
    • San Antonio, Texas, United States, 78240
      • Medical Center Opthamology Assoc .
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Eye Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Signed informed consent must be obtained prior to participation
• Able to complete adequate fundus photographs and retinal images
• Diagnosis of type 1 or 2 Diabetes Mellitus (DM) and HbA1c less than or equal to 12% at screening
• DM treatment stable for at least 3 months
• PDR diagnosis with no previous PRP treatment in the study eye

Exclusion Criteria:

• Concomitant conditions or ocular disorders in the study eye at Screening or Baseline that could compromise a response to study treatment.
• Presence of diabetic macular edema in the study eye
• Active infection or inflammation in the study eye
• Uncontrolled glaucoma (IOP greater than 25 mmHg)
• Intravitreal anti-VEGF treatment within 6 months
• Treatment with intraocular corticosteroids
• End stage renal disease requiring dialysis or kidney transplant
• Uncontrolled blood pressure
• Systemic anti-VEGF therapy at any time

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brolucizumab Arm; Intra-vitreal injection	Biological: Brolucizumab 6 mg; 3 x q6w loading injections, followed by q12w maintenance through Week 90; Other Names: RTH258
Active Comparator: Panretinal photocoagulation laser Arm; laser	Procedure: Panretinal photocoagulation laser; initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed; Other Names: PRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in BCVA	To demonstrate that brolucizumab is non-inferior to PRP with respect to the change from Baseline in visual acuity at Week 54	At Week 54

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with no PDR at Week 54	To demonstrate that brolucizumab is superior to PRP in reducing diabetic retinopathy severity at Week 54	At Week 54
Proportion of subjects with center-involved DME up to Week 54	To demonstrate that brolucizumab is superior to PRP in preventing the development of center-involved DME up to Week 54	At Week 54
Area under the curve in change from Baseline in BCVA up to Week 54 and Week 96	To compare the effect of brolucizumab relative to PRP with respect to visual acuity	From Baseline in BCVA up to Week 54 and Week 96
Change from Baseline in ETDRS Diabetic Retinopathy Severity Scale (DRSS) score at Week 54 and Week 96	To compare the effect of brolucizumab relative to PRP on diabetic retinopathy status	From Baseline score to Week 54 and Week 96
Proportion of subjects with no PDR at Week 96	To compare the effect of brolucizumab relative to PRP on diabetic retinopathy status	At Week 96
Proportion of study eyes developing vision-threatening complications associated with diabetic retinopathy up to Week 54 and Week 96	To compare the effect of brolucizumab relative to PRP on ocular complications	At Week 54 and Week 96
Proportion of subjects with center-involved DME up to Week 96	To compare the effect of brolucizumab relative to PRP on ocular complications	At Week 96

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2020
• Primary Completion (Actual): October 30, 2023
• Study Completion (Estimated): August 20, 2024

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: proliferative diabetic retinophathy, retinal neovascularization, anti-VEGF, brolucizumab, intravitreal injection, panretinal photocoagulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: CRTH258D2301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No